429 reports
ML-device safety events analysed
What the research found
An analysis of the FDA's MAUDE adverse-event database identified 429 safety reports involving ML-enabled devices. Because reports are voluntary and self-classified — and model underperformance often only shows in aggregate — the recorded toll almost certainly understates reality.
Why it matters for providers
The one place harms are officially logged is incomplete by design, so the true real-world toll is hidden from view.
Original source
AHRQ PSNet (analysis of FDA MAUDE)
A reputable institutional report or news outlet.